NCT03005262No Longer Available不适用
Expanded Access To MLN8237, For An Individual Patient With Adenocarcinoma Of The Prostate (CTMS# 16-0122)
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- No Longer Available
研究概览
简要总结
To allow a patient continued access to MLN8237
详细描述
Expanded access to MLN8237 for an individual patient with adenocarcinoma of the prostate
研究设计
- 研究类型
- Expanded Access
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •18 years or older
- •Histologically or cytologically confirmed advanced tumors and candidates for docetaxel treatment
- •Measurable or evaluable disease is required. Patients must have clinical evidence of progressive disease or persistent disease
- •Patients with castration-resistant prostate cancer (CRPC) are required to have
- •Pathologically confirmed adenocarcinoma of the prostate
- •Evidence of metastatic disease on bone scan or other imaging. Patients with PSA elevation as the only manifestation of disease are not eligible.
- •Progressive disease after at least 1 hormonal treatment with documented testosterone levels less than 50 ng/dl
- •Concurrent use of an agent for testosterone suppression (e.g., LHRH agonist) is required if the patient has not been surgically castrated
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- •Recovered to less than or equal to Grade 1 toxicity (CTCAE), to patient's baseline status (except alopecia) or deemed irreversible from the effects of prior cancer therapy and must have evidence of progressive or persistent disease
- •Adequate bone marrow, liver and renal function
- •Any use of opiates must be stable for at least 2 weeks prior to study entry
- •Male patients who agree to practice effective barrier contraception during the entire study and through 6 months after the last dose of study drug OR agree to abstain from heterosexual intercourse
- •Voluntary written consent
- •Willing to comply with scheduled visits, treatment plan, laboratory tests and other trial procedures
- •Suitable venous access for blood sampling
排除标准
- •Antineoplastic therapy or any experimental therapy within 21 days before the first dose of MLN8237
- •Prior or current investigational therapies within 4 weeks before the first dose of MLN8237
- •Radiotherapy to greater than 40% of bone marrow or any radiotherapy (except localized, small field radiation) within 4 weeks prior to enrollment, unless reviewed and approved by the medical monitor
- •Nitrosoureas or mitomycin-C within 6 weeks before the first dose of MLN
- •Autologous stem cell transplant within 3 months before the first dose of MLN8237, or prior allogeneic stem cell transplant at any time.
- •Use of enzyme-inducing antiepileptic drugs such as phenytoin, carbamazepine or phenobarbital, or rifampin, rifabutin, rifapentine or St. John's wort within 14 days prior to the first dose of MLN8237
- •For CRPC patients:
- •Radiotherapy or antiandrogen therapy for prostate cancer within 4 weeks prior to enrollment
- •Prior treatment with antineoplastic chemotherapy or radioisotopes for advanced prostate cancer
- •Use of products known to affect PSA levels within 4 weeks of enrollment
- •Major surgery within 4 weeks of study enrollment
- •Uncontrolled high blood pressure
- •Patients with abnormal gastric or bowel function or who require continuous treatment with antacids or proton pump inhibitors
- •Patients receiving chronic steroid therapy other than the following: low dose steroid for the control of nausea and vomiting, topical steroid, inhaled steroid or use of dexamethasone
- •Known severe hypersensitivity to docetaxel or other drugs formulated in polysorbate 80
- •Comorbid condition or unresolved toxicity that would preclude administration of docetaxel
- •Prior history of Grade 2 or greater neurotoxicity or any toxicity that has not resolved to Grade 1 or below
- •Symptomatic brain or other CNS metastasis
- •Diagnosis or treatment of another malignancy within 2 years preceding first dose of study drug except nonmelanoma skin cancer or in situ malignancy completely resected
- •Known history of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C
- •Patients requiring full systemic anticoagulation
- •Prior allogeneic bone marrow or other organ transplant
- •Active infection requiring systemic therapy within 14 days preceding first dose, or other serious infection
- •History of hemorrhagic or thrombotic cerebrovascular event in the past 12 months
- •Serious medical or psychiatric illness that could interfere with protocol completion
- •Inability to swallow oral medication
- •Prior treatment with more than 3 myelosuppressive cytotoxic chemotherapy regimens
- •Prior treatment with more than 1 prior taxane-containing regimen
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